Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

Suicide and Self-harm Clinical Trial

Official title:

Developing and Feasibility Testing of a Brief Contact Intervention to Reduce Self-harm Repetition Through Co-design.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530018
• Other study ID #: 202206137RINA
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: July 2024

Study information

• Verified date: September 2022
• Source: National Taiwan University Hospital
• Contact: Shu-Sen Chang, MD, MSc, PhD
• Phone: +886 2 33668062
• Email: shusenchang[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Suicide is a major public health issue. Repeated self-harm may lead to potential future suicide deaths. In addition, it may lead to substantial loss in medical costs. Recently, smartphones have been widely used. Researchers started to apply mobile health to support individuals with self-harm experiences and to combine brief contact interventions which require lower cost to reduce repeated self-harm. However, the research evidence remains sparse. Furthermore, self-harm behaviors might be influenced by different cultural contexts. There is a need to conduct local studies in Taiwan. The aim of this study is to establish a co-design team which includes service users and service providers, to collaboratively develop a text- and web-based brief contact intervention (BCI) to reduce repeated self-harm, and to evaluate the feasibility of the intervention.

Description:

Study objectives: 1. To establish a co-design team and develop a brief contact intervention (BCI), including the content, frequency, settings, and outcome measures of the intervention. 2. To evaluate the feasibility of BCI, including the feasibility of recruitment, required resources, the appropriateness of data collection, and the acceptability of the BCI. Methods: 1. In study 1, we will recruit 4-6 service users and 4-6 service providers respectively, and we will conduct focus groups to discuss the content of the BCI. We will conduct individual interviews with participants to explore their experiences and perspectives regarding their participation in the co-design team. 2. In study 2, we will recruit 30 participants who have self-harm experiences to participate in the BCI. The BCI will be delivered through texts and web pages and will last around 5 months. The content of BCI will include caring messages, reminders of appointments, safety planning, volitional help sheet, and resources information. We will collect user engagement data and compare study outcomes (e.g., suicidal ideation and behaviors, brief symptom rating scale (BSRS), and mental well-being scale) before and after receiving the BCI. We will collect the participants' feedback regarding the BCI and evaluate the required resources to further revise the BCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Aged 20 years or over
• Mentally and physically stable and able to participate in individual interviews and interventions
• Able to communicate in Mandarin and provide written informed consent
• Willing to be recorded during the interviews
• Received medical treatments or aftercare due to self-harm experiences, including self-harm ideations, self-harm behaviors, suicidal ideations, and suicidal attempts.
• Able to use the smartphone to access the internet

Exclusion Criteria:

• Mental and physical states are unstable (e.g., unconscious, severe psychiatric symptoms, strong suicidal ideations with specific suicide plans) to complete the interviews and interventions according to the health professionals.

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicide
• Suicide and Self-harm

Intervention

Behavioral:
• Brief contact intervention
The brief contact intervention (BCI) will send out text messages to the participants. The text messages will include caring messages, reminders of appointments, and a link to a web page. The web page is anticipated to include safety planning, volitional helpsheet, and resources information. The text messages are anticipated to send out to the participants on a weekly base for 6 weeks in a row, and then change to monthly reminders. The monthly reminders are anticipated to include caring messages, reminders of appointments, and invitations to encourage the participants to click the previous web links again. The monthly reminders are anticipated to send out to the participants three times in a row. In the final reminder, the participants will be told that this intervention is going to end. In total, the participants will receive 9 texts within 5 months.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The acceptability of the intervention to participants	The investigators will conduct face-to-face qualitative interviews to understand the acceptability of the intervention amongst participants.	within 6 months of study completion
Primary	The feasibility of intervention to participants	The investigators will conduct face-to-face qualitative interviews to understand the feasibility of intervention amongst participants.	within 6 months of study completion
Primary	Participant recruitment	Recruitment: the proportion of participants who are eligible and invited actually consent to participate.	through study completion, an average of 1 year
Primary	Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 1 month follow-up.	1 month
Primary	Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 3 month follow-up.	3 month
Primary	Participant retention rate	The proportion of participants who can be reached by in-person or phone contact at the 6 month follow-up.	6 month
Primary	Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 1 month after intervention based on self-report.	1 month
Primary	Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 3 month after intervention based on self-report.	3 month
Primary	Number of repeated self-harm episodes (self-report)	Number of repeated self-harm episodes per person at 6 month after intervention based on self-report.	6 month
Primary	Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 1 month after intervention recorded in the nationwide self-harm registry	1 month
Primary	Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 3 month after intervention recorded in the nationwide self-harm registry	3 month
Primary	Number of repeated self-harm episodes (nationwide self-harm registry)	Number of repeat self-harm episodes per person at 6 month after intervention recorded in the nationwide self-harm registry	6 month
Secondary	Self-efficacy and stages of change questionnaire	Access participants' self-efficacy and stages of change in relation to suicide ideation and attempt at 1/3/6 month.	1 month, 3 months, 6 months
Secondary	Help-seeking behavior questionnaire	Assess the help-seeking behaviors of participants at 1/3/6 month.	1 month, 3 months, 6 months
Secondary	Brief Symptom Rating Scale (BSRS)	Briefly evaluate the psychological distresses of participants at 1/3/6 month. The total score ranges from 0 to 25. Categorized as "mild" with score 6-9, "moderate" with score 10-14, and "severe" with score more than 15.	1 month, 3 months, 6 months
Secondary	The World Health Organisation- Five Well-Being Index (WHO-5)	Measure the current mental wellbeing of participants at 1/3/6 month.	1 month, 3 months, 6 months